FDA 510(k), K133864, DERMABOND PRINEO SKIN CLOSURE SYSTEM

FDA 510(k), K133864, DERMABOND PRINEO SKIN CLOSURE SYSTEM

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510(K) Number: K133864
Device Name: DERMABOND PRINEO SKIN CLOSURE SYSTEM
Manufacturer: DONNA MARSHALL
Device Classification Name: Cutaneous Tissue Adhesive With Mesh
Regulation Number: OMD
Classification Product Code: KXA
Date Received: 12/19/2013
Decision Date: 03/10/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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